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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K241145
Device Name TLAB® Transvenous Liver Biopsy System (TF-18C)
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Jacquelyn Huyghue
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Jacquelyn Huyghue
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/25/2024
Decision Date 08/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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